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PharmaCompass offers a list of Zidovudine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Zidovudine manufacturer or Zidovudine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zidovudine manufacturer or Zidovudine supplier.
PharmaCompass also assists you with knowing the Zidovudine API Price utilized in the formulation of products. Zidovudine API Price is not always fixed or binding as the Zidovudine Price is obtained through a variety of data sources. The Zidovudine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zidovudine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zidovudine, including repackagers and relabelers. The FDA regulates Zidovudine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zidovudine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Zidovudine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zidovudine supplier is an individual or a company that provides Zidovudine active pharmaceutical ingredient (API) or Zidovudine finished formulations upon request. The Zidovudine suppliers may include Zidovudine API manufacturers, exporters, distributors and traders.
click here to find a list of Zidovudine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zidovudine DMF (Drug Master File) is a document detailing the whole manufacturing process of Zidovudine active pharmaceutical ingredient (API) in detail. Different forms of Zidovudine DMFs exist exist since differing nations have different regulations, such as Zidovudine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zidovudine DMF submitted to regulatory agencies in the US is known as a USDMF. Zidovudine USDMF includes data on Zidovudine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zidovudine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zidovudine suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Zidovudine Drug Master File in Korea (Zidovudine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zidovudine. The MFDS reviews the Zidovudine KDMF as part of the drug registration process and uses the information provided in the Zidovudine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zidovudine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Zidovudine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zidovudine suppliers with KDMF on PharmaCompass.
A Zidovudine CEP of the European Pharmacopoeia monograph is often referred to as a Zidovudine Certificate of Suitability (COS). The purpose of a Zidovudine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zidovudine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zidovudine to their clients by showing that a Zidovudine CEP has been issued for it. The manufacturer submits a Zidovudine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zidovudine CEP holder for the record. Additionally, the data presented in the Zidovudine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zidovudine DMF.
A Zidovudine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zidovudine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Zidovudine suppliers with CEP (COS) on PharmaCompass.
A Zidovudine written confirmation (Zidovudine WC) is an official document issued by a regulatory agency to a Zidovudine manufacturer, verifying that the manufacturing facility of a Zidovudine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zidovudine APIs or Zidovudine finished pharmaceutical products to another nation, regulatory agencies frequently require a Zidovudine WC (written confirmation) as part of the regulatory process.
click here to find a list of Zidovudine suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Zidovudine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zidovudine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Zidovudine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Zidovudine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zidovudine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zidovudine suppliers with NDC on PharmaCompass.
Zidovudine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Zidovudine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Zidovudine GMP manufacturer or Zidovudine GMP API supplier for your needs.
A Zidovudine CoA (Certificate of Analysis) is a formal document that attests to Zidovudine's compliance with Zidovudine specifications and serves as a tool for batch-level quality control.
Zidovudine CoA mostly includes findings from lab analyses of a specific batch. For each Zidovudine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Zidovudine may be tested according to a variety of international standards, such as European Pharmacopoeia (Zidovudine EP), Zidovudine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zidovudine USP).